FDA UDI
In Commercial Distribution
🇺🇸 United States
Stephens Instruments
DI: 00810799039514
·
Model: SSD4 1457
·
KRISHNA IMPORTS INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Stephens Instruments
- Primary DI
- 00810799039514
- Version / Model
- SSD4 1457
- Catalog Number
- SSD4 1457
- Company Name
- KRISHNA IMPORTS INC
- Labeler DUNS
- 081853285
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-23
- Public Version
- 1
- Public Version Date
- 2020-10-01
- Public Version Status
- New
- Public Device Record Key
- 6335e067-3a22-4105-9dac-8b00474c67e1
Device Description
Braunstein Fixed Caliper, Incision Gauge, 3.5mm/4.0mm, Single Use, 10/Box
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HOE | Caliper, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64447 | Ophthalmic angular gauge, single-use | A non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810799039507 | GS1 | box | 10 | In Commercial Distribution | |
| Primary | 00810799039514 | GS1 |
Customer Contacts
- Phone
- +1(859)259-4925
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature